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Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

NCT ID: NCT01374490

Last Updated: 2020-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-07

Study Completion Date

2012-10-31

Brief Summary

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This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

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Detailed Description

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Conditions

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HIV Enteropathy Diarrhea With HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crofelemer

Group Type EXPERIMENTAL

Crofelemer

Intervention Type DRUG

Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

Interventions

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Crofelemer

Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 18 years old
* History of HIV-1 infection
* On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
* Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

Exclusion Criteria

* CD4 counts \< 100 cells/mm3
* Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
* Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
* Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Bakersfield, California, United States

Site Status

Beverly Hills, California, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Miami Beach, Florida, United States

Site Status

Wilton Manors, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Detroit, Michigan, United States

Site Status

Santa Fe, New Mexico, United States

Site Status

New York, New York, United States

Site Status

Rochester, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CFHD3092

Identifier Type: -

Identifier Source: org_study_id

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